Salvia Miltiorrhiza And Pseudo-ginseng Ningxin Tablets Treatment Of Stable Angina Pectoris (Blood Stasis Syndrome) Clinical Research

Objective Evaluate the clinical effect and safety of Salvia miltiorrhiza and pseudo-ginseng ningxin tablets in the curation of stable angina pectoris(blood stasis syndrome),and get the topgallant dose of clinical treatment.Methods1.This test follow the parallel randomized,double blind,placebo controlled,multicenter clinical trial.Test object:angina pectoris grade I,II,III,TCM for patients with qi stagnation and blood stasis syndrome.480 patients were enrolled.After 2 weeks,they were randomly splited into test team(n=360)and control group(n=120),and the course of treatment was 12 weeks.The experiment was studied in the 15 clinical trial center respectively,a total of 36 pationts selected by our center were randomly splited into three groups,namely: the test team 1,a total of 12(Salvia miltiorrhiza and pseudo-ginseng ningxin tablets 2 pills / time,2times / day,oral),experimental group 2,a total of 12 cases(Salvia miltiorrhiza and pseudo-ginseng ningxin tablets 4 pills / time,2times / day,oral)and control group(Salvia miltiorrhiza and pseudo-ginseng ningxin tablets(1 bags / times,2 time / day,oral).2.Through the observation of this subjects before and after the treatment of angina pectoris symptoms(frequency,degree of pain,duration of seizure),angina score,curative effect and integral of TCM Syndromes,and the ECG,treadmill exercise test,evaluation of Salvia miltiorrhiza and pseudo-ginseng Ningxin tablets in the treatment of coronary heart disease and angina pectoris(blood stasis syndrome)is effective.3.By observing the vital signs,the three routine,,liver function,renal function,blood coagulation before and after treatment,and adverse events of the patients,to evaluate their safety.4.All the data were analyzed by SAS 9.1.3 software.Result1.There is no obvious distinction among the three teams in gender,age,basic disease,angina classification,angina attack frequency(P >0.05).So they are comparable.2.The curative effection of angina pectoris : the effective rate of the experimental group 1 was 66.7%,the effective rate of the experimental group 2 was 75.0%,and the control group was 25%;there was obvious distinction in the experimental group 1,the test team2 and the control group(P <0.05).3.The curative effection of TCM syndrome:the effective rate of test team 1 was 66.7%,the effective rate of test team 2 was 75.0%,and the control group was 33.3%;there was obvious distinction among test team 1,test team 2 and the control group(P <0.05).4.TCM syndrome score,angina score:there was no significant difference between the three groups before the curation on TCM syndrome score and angina score(P >0.05),they are comparable.After treatment,the TCM syndrome scores and angina scores of all patientswas lower than before treatment.After treatment,TCM syndrome score and angina score of the test team 1 and team 2 were evidently lower than those in the control group(P <0.05),and that in test team2 was lower than in test team 1.The difference was statistically significant(P <0.05).5.The ECG effection :the effective percentage of the experimental group 1 was 25.0%,the effective percentage of the test team 2 was58.3%,and the control group was 8.3%;there was distinct difference among the test team 1,the test team 2 and the control group(P<0.05).6.Treadmill exercise test:before the start of the test,there was no obvious distinction among the three groups about the time required from the start of the campaign to the positive standard(P >0.05),there was no statistical significance.Compared with the control group,the experimental group 1 and the experimental group 2 were all longer after test(P <0.05),the difference was statistically significant.7.During the experiment,three groups of subjects showed no obvious abnormalities in the vital signs,blood routine,urine routine,stool routine,four items of blood coagulation,liver function,renal function.And no adverse events occurred in the three groups during the experiment.Conclusion Salvia miltiorrhiza and pseudo-ginseng Ningxin tablets in treatment of angina pectoris(blood stasis syndrome)is safe and effective.According to the results of clinical trials,it is suggested that the clinical dosage of Salvia miltiorrhiza and pseudo-ginseng Ningxin tablets in clinical trial is about 2 times a day,each time 4 tablets.